Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit

Solid Tumor, Adult Clinical Trial

— CPV2-0  

Official title:

Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03977766
• Other study ID #: CPV 2.0-IPC 2018-054
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: April 15, 2021

Study information

• Verified date: June 2019
• Source: Institut Paoli-Calmettes
• Contact: Dominique Genre, MD
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.

After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age <80 (if age>70 years, a G8 score>14 is required)

• ECOG<3

• Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)

• Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15

• Familiar with digital tools

Exclusion Criteria:

• Emergency

• patient feeling unease with the use of a smartphone

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Procedure:
• Chemotherapy prevalidation
Outpatient Chemotherapy prevalidation will done with the help of a nurse, using the digital application, for cycle 2 and 3. by the patient alone, using the digital application, for cycle 4 and 5.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the digital application	Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician	6 weeks